# K123855: Water-Filled Teether

- Pathway: 510(k) (Traditional)
- Applicant: Solid Toys Ind., Ltd.
- Decided: May 24, 2013 after 161 days
- Product code: KKO (Ring, Teething, Fluid-Filled)
- Device class: 2
- Regulation: 21 CFR 872.5550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K052105 (2005). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992384: Cpap/Pro Cpap Interface, Stevenson Industries, Inc. (1999) Summary page 1.
- K092781: Mam Twister, Mam International AG (2010) Summary page 1.

## Indications for use
Indicated to soothe and cool teething babies and help reduce teething pain.

Source page: https://510kreport.com/device/K123855
Methodology: https://510kreport.com/methodology